68 -- Anthrax recombinant Protective Antigen (rPA) vaccine for the Strategic National Stockpile (SNS)

THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL. This notice does not constitute a commitment by the Government. The Government is currently conducting market research in accordance with Federal Acquisition Regulation, Part 10 to identify potential sources to provide the requirement and to gather information on current capabilities within the market. All information submitted in response to this sources sought notice is voluntary and the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. Proprietary information submitted should be marked appropriately. The Department of Health & Human Services has a future need for 25 million doses of an anthrax recombinant Protective Antigen (rPA) vaccine in which it is reasonable to assume that it will be licensed within 8 years by the U.S. Food & Drug Administration/Center for Biologics Evaluation & Research (FDA/CBER) and is stable at least 24 months, with options for up to an additional 40 million doses. A potential offeror must meet the following mandatory criteria for eligibility: 1. A Food and Drug Administration (FDA) Investigational New Drug (IND) application not currently on clinical hold, and Phase 2 clinical safety and immunogenicity data using anthrax (rPA) vaccine. 2. Demonstrated validated bulk drug substance (BDS) production at the proposed commercial scale. 3. Rabbit and non-human primate proof-of-concept efficacy data using anthrax spore aerosol challenge models. 4. Obtained FDA's Current Thinking describing the minimum product information and data that shall be submitted to the FDA for review in order to potentially consider use of the product in a declared emergency under Emergency Use Authorization (EUA). It is anticipated that a solicitation will be announced in July, with proposals due in November. While the mandatory criteria for eligibility do not have to currently be met, all of the mandatory criteria for eligibility must be met by proposal submission. Proposals that do not meet the mandatory criteria for eligibility would not be considered for evaluation. Interested parties may identify their interest by submitting a capability statement including how they meet the mandatory criteria for eligibility, an anticipated product delivery schedule, primary contact information at the organization (name, email, address, and telephone number) for this sources sought notice in the event that HHS has additional questions or requires clarification on the submitted information. Responses are limited to 10 pages. Data sets (e.g., tables, charts, graphs) and documents which are pertinent to the response can be submitted as appendices to the primary submission. Respondents are also requested to specify whether they are a large business or small business. All respondents and comments to this announcement shall reference "DHHS-Sources Sought - Anthrax rPA vaccine - June 2007" and be submitted to Brian K. Goodger, Contracting Officer, at Brian.Goodger@hhs.gov and Michelle Gray, contract specialist, at Michelle.Gray@hhs.gov by COB on June 11, 2007. All submitted information shall remain with the U.S. Government and will not be returned.